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Insulet (PODD): recalls and clinical trials

Insulet (PODD) beyond its filings: 4 recalls in the last 12 months (10 in five years, 6 Class I); 6 active clinical trials.

Latest recalls

2026-07-08 · FDA device · Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod).
2026-07-08 · FDA device · Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1
2026-07-08 · FDA device · Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod).
2026-04-22 · FDA device · Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
2025-10-22 · FDA device · The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying f
2025-07-02 · FDA device · Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod
2024-01-10 · FDA device · Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Goo
2023-09-27 · FDA device · Omnipod 5 Automated Insulin Delivery System

Insulet's latest quarter

Insulet, Q3 2026: revenue $842M (+19% year over year), operating margin 22.5%, net earnings $141M, operating cash flow $124M. The chart follows the revenue to costs, profit and cash.

Questions

Has Insulet had any recalls?

10 recalls on file over five years from the FDA, CPSC and NHTSA; 4 in the last 12 months.

How many clinical trials does Insulet have?

6 active studies on ClinicalTrials.gov, 0 in phase 3.

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Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.